Liver TransplantationPhase 3EGRADICATENCT02890719
Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients.
A Phase 3 study testing Grazoprevir 100 mg/day, Elbasvir 50 mg/d and Elbasvir 50 mg/day in people with Liver Transplantation and Hepatitis C, run by Fundacion Clinic per a la Recerca Biomédica.
Trial summary
Pilot, single center, open-label study to evaluate the efficacy and tolerability of Grazoprevir and Elbasvir in HCV GT1 and 4 liver transplant recipients.30 liver transplant recipients with hepatitis C recurrence. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Liver Transplantation, Hepatitis C
- What is being tested?
- Grazoprevir 100 mg/day, Elbasvir 50 mg/d and Elbasvir 50 mg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Aug 2016to 1 Jun 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 78 year-old.
- Previous liver transplantation(more than 6 month).
- Genotype 1 and 4 infection.
- Hepatitis C recurrence defined by the presence of abnormal liver function test, positive HCV-RNA, histological signs of hepatitis C recurrence.
- Viral load ≥10000UI/mL.
- Immunosuppression with tacrolimus and/or mycophenolate (Prednisone use is allowed at low dose, ≤10 mg/d).
- Treatment naïve or treatment experienced (Peg-RBV or triple therapy).
Who cannot join
- Genotype 2, 3, 5 or 6 infection.
- Decompensated cirrhosis defined by the presence of actual or previous history of clinical decompensation including ascites, hepatic encephalopathy, variceal bleeding or spontaneous bacterial peritonitis, or a Child-Pugh B or C.
- Hepatocellular carcinoma after liver transplantation.
- Total bilirubin > 3 mg/dL.
- Immunosuppression with cyclosporine or an mTOR inhibitor (everolimus or sirolimus).
- Severe extrahepatic diseases: cardiovascular, respiratory, cerebrovascular and poorly controlled diabetes.
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- Platelets < 75 x 109 cells/L.
- Neutrophil count < 0.5 x 109 cells/L.
- Hemoglobin < 9 g/dL.
- Albumin < 3g/dL.
- HIV infection.
- Hepatitis B infection.
- Active intake of toxic amounts of alcohol or recreational drugs.
- Females who are pregnant, become to be pregnant or breastfeeding or males whose partners are pregnant, become to be pregnant or breastfeeding.
- Intake of disallowed medications including(but not limited to):
- Antibiotics: clarithromycin, erythromycin, telithromycin, nafcillin, rifampin
- Antifungals: itraconazole, ketoconazole, voriconazole
- Antihypertensives: nifedipine
- Anticonvulsants: carbamazepine, phenytoin, phenobarbital
- Bosentan
- Modafinil
- St.Jonh's Wort
- Immunosuppressants: cyclosporin, everolimus, sirolimus
- Diabetes agents: glibenclamide, glyburide
- Lipid lowering agents: gemfibrozil
- Eltrombopag
- Lapatinib
- HIV medications: efavirenz, etravirine, all ritonavir boosted and unboosted HIV protease inhibitors
- Statins: simvastatin, fluvastatin, rosuvastatin at doses greater than 10 mg/d, atorvastatin at doses greater than 10 mg/d.
About this study
Pilot, single center, open-label study to evaluate the efficacy and tolerability of Grazoprevir and Elbasvir in HCV GT1 and 4 liver transplant recipients.30 liver transplant recipients with hepatitis C recurrence.
- Conditions
- Liver Transplantation, Hepatitis C
- Being tested
- Grazoprevir 100 mg/day, Elbasvir 50 mg/d, Elbasvir 50 mg/day, Ribavirin 1200 mg/day
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grazoprevir 100 mg/dayDrug
Also called J05AX68 100 mg
Grazoprevir 100 mg/ day 12 weeks
Elbasvir 50 mg/dDrug
Also called J05AX68 50mg
Elbasvir 50 mg/day 12 weeks
Grazoprevir 100 mg/dayDrug
Also called J05AX68 100 mg
Grazoprevir 100 mg/day 16 weeks
Elbasvir 50 mg/dayDrug
Also called 50mg J05AX68
Elbasvir 50 mg/d 16 weeks
Ribavirin 1200 mg/dayDrug
Also called J05AB04 1200 mg/d
Ribavirin 1200 mg/day 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Genotype 1B | Experimental | treatment 12 weeks Receives: Drug: Grazoprevir 100 mg/day; Drug: Elbasvir 50 mg/d |
| Genotype 1A and 4 | Experimental | treatment 16 weeks Receives: Drug: Grazoprevir 100 mg/day; Drug: Elbasvir 50 mg/day; Drug: Ribavirin 1200 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response
Sustained virological response 12 w (SVR24) defined as HCV-RNA undetectable at post-treatment week 12.
Measured: 12 weeks post-treatment
Secondary outcomes (4)
Sustained virological response
Sustained virological response 12 ( SVR12) defined as HCV-RNA undetectable at post-treatment weeks 4 and , 24 respectively.
Measured: 4 weeks and 24 weeks post-treatment
To evaluate the beneficial effects of antiviral therapy on renal function.
creatinine sample analyses blood analyses in all visits
Measured: 24 weeks post-treatment
To assess the impact of therapy in kidney function.
Elevation Transaminases blood analyses in all visits
Measured: 24 weeks post-treatment
Tolerability of this combination in liver transplant recipients.
Serious advers events evaluation
Measured: Every visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start3 Aug 2016
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Why it stopped: Impossibility of supplying the medication in research of the study by the pharmaceutical company that gave it to the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890719
- Sponsor's protocol ID
- EGRADICATE
- Other IDs
- 2015-005453-13, 2015
- Acronym
- EGRADICATE
- Status last verified
- Jun 2025
- First submitted
- 24 Aug 2016
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients.
- ClinicalTrials.gov ID
- NCT02890719
- Acronym / sponsor ID
- EGRADICATE / EGRADICATE
- Conditions
- Liver Transplantation, Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Impossibility of supplying the medication in research of the study by the pharmaceutical company that gave it to the trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 3 Aug 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot, single center, open-label study to evaluate the efficacy and tolerability of Grazoprevir and Elbasvir in HCV GT1 and 4 liver transplant recipients.30 liver transplant recipients with hepatitis C recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genotype 1B | Experimental | Drug: Grazoprevir 100 mg/day, Drug: Elbasvir 50 mg/dtreatment 12 weeks |
| Genotype 1A and 4 | Experimental | Drug: Grazoprevir 100 mg/day, Drug: Elbasvir 50 mg/day, Drug: Ribavirin 1200 mg/daytreatment 16 weeks |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 78 year-old.
- Previous liver transplantation(more than 6 month).
- Genotype 1 and 4 infection.
- Hepatitis C recurrence defined by the presence of abnormal liver function test, positive HCV-RNA, histological signs of hepatitis C recurrence.
- Viral load ≥10000UI/mL.
Key exclusion criteria (29 listed)
- Genotype 2, 3, 5 or 6 infection.
- Decompensated cirrhosis defined by the presence of actual or previous history of clinical decompensation including ascites, hepatic encephalopathy, variceal bleeding or spontaneous bacterial peritonitis, or a Child-Pugh B or C.
- Hepatocellular carcinoma after liver transplantation.
- Total bilirubin > 3 mg/dL.
- Immunosuppression with cyclosporine or an mTOR inhibitor (everolimus or sirolimus).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grazoprevir 100 mg/dayAlso: J05AX68 100 mgGrazoprevir 100 mg/ day 12 weeks | Drug | Genotype 1B |
| Elbasvir 50 mg/dAlso: J05AX68 50mgElbasvir 50 mg/day 12 weeks | Drug | Genotype 1B |
| Grazoprevir 100 mg/dayAlso: J05AX68 100 mgGrazoprevir 100 mg/day 16 weeks | Drug | Genotype 1A and 4 |
| Elbasvir 50 mg/dayAlso: 50mg J05AX68Elbasvir 50 mg/d 16 weeks | Drug | Genotype 1A and 4 |
| Ribavirin 1200 mg/dayAlso: J05AB04 1200 mg/dRibavirin 1200 mg/day 16 weeks | Drug | Genotype 1A and 4 |
Primary outcome
Sustained virological response
Time frame: 12 weeks post-treatment
Sustained virological response 12 w (SVR24) defined as HCV-RNA undetectable at post-treatment week 12.
4 secondary outcomes
Sustained virological response
Time frame: 4 weeks and 24 weeks post-treatment
To evaluate the beneficial effects of antiviral therapy on renal function.
Time frame: 24 weeks post-treatment
To assess the impact of therapy in kidney function.
Time frame: 24 weeks post-treatment
Tolerability of this combination in liver transplant recipients.
Time frame: Every visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Grazoprevir 100 mg/day, Elbasvir 50 mg/d and Elbasvir 50 mg/day in people with Liver Transplantation and Hepatitis C, run by Fundacion Clinic per a la Recerca Biomédica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained virological response (time frame: 12 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.